Drugs@FDA: FDA-Approved Drugs
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/30/1992 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/03/2016 | SUPPL-28 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/13/2012 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/27/2007 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 08/30/2001 | SUPPL-18 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-17 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/09/1998 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/09/1997 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/1996 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/1995 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 03/02/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1994 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1994 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/13/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
LOPERAMIDE HYDROCHLORIDE
CAPSULE;ORAL; 2MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE;ORAL | Prescription | No | AB | 218122 | AUROBINDO PHARMA LTD |
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE;ORAL | Prescription | No | AB | 215579 | BIONPHARMA |
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE;ORAL | Prescription | No | AB | 215001 | EDENBRIDGE PHARMS |
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE;ORAL | Prescription | No | AB | 217840 | JUBILANT CADISTA |
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE;ORAL | Prescription | No | AB | 072741 | MYLAN |
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE;ORAL | Prescription | No | AB | 216876 | RUBICON |
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE;ORAL | Prescription | No | AB | 073192 | TEVA |
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | CAPSULE;ORAL | Prescription | No | AB | 217471 | ZYDUS LIFESCIENCES |